Kornimate/medical-research-clean huggingface dataset:
double vs single intrauterine insemination in male factor infertility

Conditions: Male Factor Infertility

Summary: the aim of the study is to compare the pregnancy outcomes of single vs double intrauterine insemination (iui) in couples with male factor infertility.

the principle behind double intrauterine insemination in male factor infertility couples is to create a longer time frame for fertilization and to increase motile sperm number in female genital tract in order to increase pregnancy rates. there's a clinical equipoise on the benefits of performing double iui in couples following ovarian hyperstimulation with daily follicle stimulating hormone injections in male factor subfertility. as it is stated in cochrane database, there's a need for adequately powered, randomized, high-quality studies on this subject. in this study, as a result of a-priori power analysis 132 participants in each study arm is planned to be recruited in the study. male factor infertility included in the study is defined as total motile sperm count (tpmsc) less than 10 million. tpmsc less than 1 million, female age greater than 40, uterine anomaly, no patent tubes shown in hysterosalpingography, history of ovarian surgery and known endometriosis will be excluded. couples with two basal semen analysis with tpmsc between 1-10 million will be randomized to single or double iui procedure. to accomplish this in approximately 1 year period, the study is planned as a multi-center study. the objective of the study is to compare the pregnancy outcomes of single and double intrauterine insemination groups, following ovarian hyperstimulation in couples with male factor subfertility.

Eligibility criteria:
inclusion criteria: * couples trying to conceive for at least 6 months despite of regular sexual intercourse * female partner between 18-40 years old * male partner sperm analysis total motile sperm count between 1-10 million in at least 2 sperm analysis on different days. exclusion criteria: * no patent fallopian tubes shown in hystero-salpingography * female partner with a uterine anomaly * history of a previous ovarian surgery * known or suspected endometriosis in female partner * body-mass index (bmi) \> 40 kg/m2
point of service diabetes screening evaluation

Conditions: Diabetes Mellitus, Non-Insulin Dependent

Summary: the primary objective of the trial is to collect scout ds, random capillary glucose and hemoglobin a1c measurements from subject 18 years of age or older.

the objectives of this study are to compare the accuracy of scout versus random capillary glucose and several diabetes risk assessment questionnaires for detection of hba1c-defined dysglycemia.

Eligibility criteria:
inclusion criteria: * 18 years of age or older exclusion criteria: * known to be pregnant (self-reported) * receiving dialysis or known renal compromise * known to have photosensitivity * taking medications that fluoresce * have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm

Keywords: type 2 diabetes adults 18 years and older
newly designed fully covered metal stent for the benign biliary stricture

Conditions: Bile Duct Disease

Summary: the purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (fcsems) and anchoring fcsems for benign biliary stricture.

benign biliary strictures (bbs) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. fully covered self-expanding metal stent(fcsems) placement was reported as a useful method for bbs. however, stent migration was a frequent complication of csems placement. recently, flared end fcsems was developed to decrease stent migration, and anchoring csems was newly developed.

Eligibility criteria:
inclusion criteria: * patient over 18 years old * patient with benign bile duct stricture exclusion criteria: * no written informed consent * malignant biliary obstruction * patients with uncorrectable severe coagulopathy * patients with severe cardiopulmonary disease precluding sedation

Keywords: metal stent bile duct stricture stent migration feasibility safety removability
pharmacokinetics/pharmacodynamics (pk/pd) characteristics of tolvaptan tablet in korean healthy male

Conditions: Healthy

Summary: to investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy korean male subjects.


Eligibility criteria:
inclusion criteria: 1. healthy korean male subjects between 20 and 45 years of age, inclusive. 2. body mass index (bmi) of 20 to 26 kg/m2, body,weight ≥ 50kg bmi = weight (kg)/height2(m) 3. informed consent from the subjects exclusion criteria: 1. clinically significant abnormality of respiratory, cardiovascular, hepatic, neurologic, endocrine, hematologic, urinary, psychiatric. 2. history of gastrointestinal disease or surgery which can affect intestinal absorption of the study drug. 3. history of any significant drug allergy or hypersensitivity. 4. ast or alt \> 1.25 times upper normal limit at screening clinical laboratory test 5. supine blood pressure after resting for ≥ 3 minutes, higher than 140/90 mmhg or lower than 100/50 mmhg, supine pulse, after resting for ≥ 3 minutes, outside the range of 40 to 90 beats/minute. 6. subjects who had history of drug abuse or alcohol addiction 7. subjects who used of any prescription drug or herbal medication within 2 weeks prior to the first dosing of the study drug, or any over-the-counter or vitamin supplements within 1 week prior to the first dosing (however, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied) 8. the investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.

Keywords: healthy korean male
evaluation of proper radiofrequency catheter ablation strategy for the patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: 1. purpose of the study 1) to compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear ablation. 2. scientific evidence of the study 1. in atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality. 2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed. 3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy. 4. however, there are no consensus for proper ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation . 5. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial. 6. therefore, we will compare conventional pulmonary vein isolation with additional conventional linear ablation. 3. methods 1. treatment of all patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation. 2. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study. 4. study contents 1) to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation * compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.


Eligibility criteria:
inclusion criteria: 1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation exclusion criteria: 1. patients who do not agree with study inclusion 2. permanent af refractory to electrical cardioversion 3. af with valvular disease ≥ grade 2 4. patients with left atrial diameter greater than 60mm 5. patients with age less than 19
prediction tool for premature labour and neonatal outcome

Conditions: Premature Birth

Summary: a register and prediction model will be developed to predict the outcome of preterm labour and birth.


Eligibility criteria:
inclusion criteria: * gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children exclusion criteria: * patients who choose not to participate in the research. * intra-uterine prelabour fetal death. * fetuses or neonates with a major congenital disorder. major is defined as a disorder that has an impact on neonatal respiratory and cerebral outcome and/or long-term outcome. * postpartum transfer/outborn.
clinical trial to compare the safety and pharmacokinetics of yhp1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin

Conditions: Hypertension; Hyperlipidemia

Summary: this is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of yhp1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers hypothesis: "yhp1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.

this is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of yhp1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers. in arm1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at day1 and "yhp1604" at day22. in arm2, 30 subjects will be assigned and the subjects will be administered "yhp1604" at day1 and "telmisartan/amlodipine and rosuvastatin" at day22.

Eligibility criteria:
inclusion criteria: * healthy male with body mass index(bmi) between 18.5 and 30 kg/m2 * who has not suffered from clinically significant disease * provision of signed written informed consent exclusion criteria: * history of and clinically significant disease * a history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs * administration of other investigational products within 3 months prior to the first dosing * volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ecgs, or vital signs
study to determine the safety and effectiveness of dupilumab for treatment of atopic dermatitis (ad)

Conditions: Atopic Dermatitis (AD)

Summary: the primary objective of the study was to assess the efficacy of dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: 1. male or female, 18 years or older; 2. chronic ad that had been present for at least 3 years before the screening visit; 3. patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable; 4. willing and able to comply with all clinic visits and study-related procedures. exclusion criteria: 1. prior participation in a dupilumab clinical trial; 2. treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit; 3. the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment: * systemic corticosteroids; * immunosuppressive/immunomodulating drugs; * phototherapy for ad; 4. treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit; 5. treatment with certain biologics; 6. regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit; 7. planned major surgical procedure during the participant's participation in this study; 8. participant was a member of the investigational team or his/her immediate family; 9. treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 10. pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study; note: the information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.
circle of life. improving capacity of swampy cree community members to recognize people at risk for suicide

Conditions: Suicide

Summary: primary hypothesis: participants in the applied suicide intervention skills training (asist) gatekeeper training will be significantly more likely to have increased knowledge and preparedness to help people with suicidal ideation than participants who receive the resilience retreat. secondary hypotheses: 1. participants in asist gatekeeper training will not have higher levels of post-intervention distress or suicidal ideation compared to the resilience retreat. 2. high levels of distress, grief, and alcohol abuse will significantly impact on the learning and retention of suicide intervention skills.

inclusion criterion: all members of the swampy cree tribal communities who are currently residing on the reserves will be eligible to participate in the study. exclusion criterion: exclusion criteria for the study include being less than 16 years of age, prior training in safetalk or asist, being an elected official in a first nations community, and inability to read or write. primary outcome: skills in suicide intervention: suicide intervention response inventory.the suicide intervention response inventory (siri) will be used to detect enhancement of intervention skills in participants. the siri is a self-administered test that was designed to measure competence in choosing appropriate response to a series of clinical scenarios with suicidal individuals. research on the siri has shown its good psychometric properties, freedom from social desirability effects, and responsiveness to training in suicide prevention. it contains 25 items, each of which consists of a "client" remark and two "helper" responses. responses are judged based on response options made by highly expert suicidologists. the siri has shown good internal consistency with alpha of 0.834, and good test-retest reliability. secondary outcomes: * knowledge about suicide, attitudes toward suicide, and self-reported preparedness to intervene with suicidal behavior will be measured by a series of questions that were developed by livingworks inc. * gatekeeper behaviors will be measured similar to questions utilized by wyman in the school-based study that assess how many people had the person asked others about suicide.

Eligibility criteria:
inclusion criteria: * all members of the swampy cree tribal communities who are currently residing on the reserves will be eligible to participate in the study. exclusion criteria: * being less than 16 years of age * prior training in safetalk or asist * being an elected official in a first nations community

Keywords: suicide intervention applied suicide intervention skills training (asist) resilience retreat first nations suicide intervention and response inventory (siri)
a study with combinations of anti-lag-3 and anti-pd-1 antibodies in adult participants with advanced or metastatic melanoma (harmony head-to-head)

Conditions: Melanoma

Summary: this study is researching an experimental drug called fianlimab (also known as regn3767), combined with another medication called cemiplimab (also known as regn2810), called "study drugs". the study is focused on patients with a type of skin cancer known as melanoma. the aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name opdualag™ and approved for the treatment of melanoma in adults and children. the study is looking at several other research questions, including: * what side effects may happen from taking the study drugs. * how much study drug is in the blood at different times. * whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. participants with histologically confirmed unresectable stage iii and stage iv (metastatic) melanoma per american joint committee on cancer (ajcc), eighth revised edition. 2. participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol. 3. measurable disease per recist version 1.1. 4. eastern cooperative oncology group (ecog) performance status (ps) ≤1 5. adequate bone marrow, hepatic, and kidney function 6. known b-rapidly accelerated fibrosarcoma protein (braf) v600 mutation status or submitted sample for braf v600 mutation assessment as described in the protocol key exclusion criteria: medical conditions: 1. uveal, acral or mucosal melanoma. 2. ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol. 3. uncontrolled infection with human immunodeficiency virus (hiv), hepatitis b (hbv), or hepatitis c virus (hcv) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed. prior/concomitant therapy: 4. prior immune checkpoint inhibitor therapy other than anti-pd1/pd-l1 as described in the protocol 5. systemic immune suppression as described in the protocol. other comorbidities: 6. participants with a history of myocarditis. 7. troponin t (tnt) or troponin i (tni) \>2x institutional upper limit of normal (uln). 8. active or untreated brain metastases or spinal cord compression as described in the protocol. note: other protocol-defined inclusion/ exclusion criteria apply.

Keywords: unresectable melanoma metastatic melanoma advanced melanoma stage iii stage iv
method of pre-treatment for application of qutenza capsaicin 8% patch

Conditions: or Peripheral Nerve Injury (PNI); Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)

Summary: the summary of product characteristics (smpc) for qutenza advises that topical anaesthetic is applied prior to the application of qutenza. this is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for qutenza.

all patients will be treated with qutenza for 60 minutes. patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of qutenza. patients will be followed up for 7 days to monitor pain scores and tolerability.

Eligibility criteria:
inclusion criteria: * diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury * daily pain score ≥ 4 for average pain both at the screening visit and at the treatment visit * intact, non-irritated, dry skin over the painful area(s) to be treated exclusion criteria: * significant ongoing or recurrent pain other than due to phn or peripheral nerve injury * past or current history of type i or type ii diabetes mellitus * active malignancy or treatment for malignancy within a year prior to the treatment visit

Keywords: tramadol qutenza pre-treatment tolerability
long term study with b2036-peg

Conditions: Acromegaly

Summary: primary objective: to investigate the efficacy and safety of pegvisomant in japanese patients with acromegaly.


Eligibility criteria:
inclusion criteria: * patients with acromegaly who have received at least one dose of b2036-peg in the preceding study (a6291009). exclusion criteria: * switching to other therapeutic methods for acromegaly
continuous positive airway pressure via binasal prong vs nasal mask: a randomised controlled trial

Conditions: Bronchopulmonary Dysplasia; Death

Summary: the investigators aimed to compare the effectiveness of nasal mask and prongs used in cpap (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (mist) in preterm infants.

objective: to determine that affect the rate of (bronchopulmonary dysplasia) bpd and death of ncpap therapy with nasal prongs or nasal mask as the initial treatment for respiratory distress syndrome (rds). methods: inborn preterm infants of gestational age 26-32 weeks, with respiratory distress syndrome were enrolled in this single-centered, unblinded randomized prospective controlled trial. they were stabilized with t-piece device in delivery room. immediately after admission of neonatal intensive care unit (nicu), infants were randomly assigned to receive ncpap with either nasal prongs or mask. ncpap was continued by setting at peep as 5 to 8 cm h2o . results: 160 infants were assessed for eligibility 149 infants were randomized. finally 75 infants in group i (nasal prong) and 74 in group ii (nasal mask) were analyzed. mean gestational ages were 29.3±1.6 vs 29.1±2.0 weeks (p=0.55) and birth weights were 1225±257 vs. 1282±312 grams (p=0.22) respectively in group i and group ii. the frequency of ncpap failure within 24 hours of life was higher in group i compared to group 2 (respectively 8%, %0 , p=0.09) but difference was not significant. the outcomes of bpd and death rates did not differ among the groups ( group i 9.3% vs. group ii 9.4 %; p=0.96). conclusions: applied nasal mask is a feasible method to deliver ncpap and as effective as nasal prongs for the initial treatment of rds in preterm infants.

Eligibility criteria:
inclusion criteria: * one hundred sixty infants born at 26-32 weeks' gestation not endotracheally intubated in the delivery room (dr) exclusion criteria: * infants with major congenital anomalies, and who required intubation in the dr and no parental consent were excluded.

Keywords: preterm infants cpap bpd invasive mechanical ventilation we aimed determine that affect the rate of bpd and death of ncpap therapy with nasal prongs or nasal mask as the initial treatment for rds.